EP4009903A1 - Dérivation de pontage cardiaque externe - Google Patents

Dérivation de pontage cardiaque externe

Info

Publication number
EP4009903A1
EP4009903A1 EP20754581.5A EP20754581A EP4009903A1 EP 4009903 A1 EP4009903 A1 EP 4009903A1 EP 20754581 A EP20754581 A EP 20754581A EP 4009903 A1 EP4009903 A1 EP 4009903A1
Authority
EP
European Patent Office
Prior art keywords
heart
opening
fluid conduit
bypass fluid
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20754581.5A
Other languages
German (de)
English (en)
Inventor
Michael G. VALDEZ
Don Huy Tran
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of EP4009903A1 publication Critical patent/EP4009903A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132—End-to-end connections

Definitions

  • the present disclosure generally relates to the field of medical devices and procedures.
  • Certain physiological parameters associated with chambers of the heart can have an impact on patient health prospects.
  • high cardiac fluid pressure and/or blood flow stagnation can lead to heart failure, embolism formation, and/or other complications in some patients. Therefore, reduction of pressure and/or increase in blood flow in certain chambers of the heart can improve patient health in some cases.
  • Described herein are one or more methods and/or devices to facilitate reduction in left atrial pressure and/or increase blood flow in one or more vessels or chambers of the heart through channeling of fluid from the left side of the heart to the right side of the heart.
  • the present disclosure relates to a method of shunting blood.
  • the method comprises accessing a chest cavity of a patient, forming a first opening in a first wall of a heart of the patient, the first wall being associated with a left atrium of the heart, anchoring a first end of a bypass fluid conduit at least partially over the first opening, forming a second opening in a second wall of the heart, the second wall being associated with a right atrium of the heart, anchoring a second end of the bypass fluid conduit at least partially over the second opening, and channeling blood from the left atrium to the right atrium through the bypass fluid conduit.
  • Channeling the blood from the left atrium to the right atrium can effect a reduction in left atrial pressure.
  • the first opening is formed in a left atrial appendage portion of the left atrium.
  • the second opening can be formed in a right atrial appendage portion of the right atrium. Channeling the blood from the left atrium to the right atrium can increase blood flow in the left atrial appendage.
  • anchoring the first end of the bypass fluid conduit at least partially over the first opening comprises anchoring the first end to external tissue of the left atrium adjacent to the first opening.
  • Anchoring the first end of the bypass fluid conduit at least partially over the first opening can comprise anchoring the first end to internal tissue of the left atrium adjacent to the first opening.
  • anchoring the first end of the bypass fluid conduit comprises embedding one or more barb tissue anchors associated with the first end of the bypass fluid conduit into biological tissue adjacent to the first opening.
  • the bypass fluid conduit may comprise a frame dimensioned to extend from the first opening to the second opening and an at least partially fluid-tight covering disposed over at least a portion of the frame.
  • the frame may be disposed internal to the covering.
  • anchoring the first end of the bypass fluid conduit comprises expanding a wire coil anchor associated with the first end of the bypass fluid conduit, the wire coil having a diameter that is greater than a diameter of the first opening.
  • the present disclosure relates to a bypass fluid conduit comprising a cylindrical frame dimensioned to extend longitudinally between a left atrial appendage of a heart and a right atrial appendage of the heart, a covering disposed about at least a portion of the cylindrical frame, a first flange associated with a first end portion of the covering, and a second flange associated with a second end portion of the covering.
  • the bypass fluid conduit may further comprise one or more tissue anchors associated with the frame.
  • the one or more tissue anchors may comprise barb-type tissue anchors.
  • the one or more tissue anchors comprise a self-expanding wireform having an expanded dimension that is greater than a diameter of the frame.
  • the covering is fluid-tight.
  • the cylindrical frame can have an axially-compressible portion configured to allow for axial contraction.
  • the bypass fluid conduit can further comprise a valve component disposed at least partially within the frame, wherein the valve component is configured to allow fluid flow in a first direction from a first end of the frame to a second end of the frame and at least partially restrict fluid flow from the second end of the frame to the first end of the frame.
  • the valve component can comprise a plurality of leaflets.
  • the present disclosure relates to a method of shunting blood.
  • the method comprises accessing a chest cavity of a patient, forming a first opening in a first wall of a heart of the patient, the first wall being associated with a left atrium of the heart, anchoring a first end of a bypass fluid conduit at least partially over the first opening, forming a second opening in a second wall of the heart, the second wall being associated with a right ventricle of the heart, anchoring a second end of the bypass fluid conduit at least partially over the second opening, and channeling blood from the left atrium to the right ventricle through the bypass fluid conduit.
  • Anchoring the second end of the bypass fluid conduit at least partially over the second opening can comprise anchoring the second end to external tissue of the right ventricle adjacent to the second opening. In some implementations, anchoring the second end of the bypass fluid conduit at least partially over the second opening comprises anchoring the second end to internal tissue of the right ventricle adjacent to the second opening. In some implementations, anchoring the second end of the bypass fluid conduit at least partially over the second opening comprises embedding one or more barb tissue anchors associated with the second end of the bypass fluid conduit into biological tissue adjacent to the second opening.
  • anchoring the second end of the bypass fluid conduit at least partially over the second opening comprises expanding a wire coil anchor associated with the second end of the bypass fluid conduit within the right ventricle, the wire coil having a diameter that is greater than a diameter of the second opening.
  • the bypass fluid conduit can comprise a frame dimensioned to extend from the first opening to the second opening and an at least partially fluid-tight covering disposed over at least a portion of the frame.
  • Figure 1 provides a perspective view of an example human heart.
  • Figure 2 shows a cross-sectional view of an example human heart.
  • Figure 3 illustrates a heart having a fluid bypass conduit device implanted thereto in accordance with one or more embodiments.
  • Figure 4 illustrates a heart having a fluid bypass conduit device implanted thereto in accordance with one or more embodiments.
  • Figure 5 illustrates a heart having a fluid bypass conduit device implanted thereto in accordance with one or more embodiments.
  • Figure 6 illustrates a heart having a fluid bypass conduit device implanted thereto in accordance with one or more embodiments.
  • Figure 7 illustrates a heart having a fluid bypass conduit device implanted thereto in accordance with one or more embodiments.
  • Figure 8 illustrates an embodiment of a fluid bypass conduit device in accordance with one or more embodiments.
  • Figure 9 shows a top-down atrial cross-sectional view of a human heart having a fluid bypass conduit device implanted thereto in accordance with one or more embodiments.
  • Figure 10 is a flow diagram illustrating a process for fluid shunting in cardiac anatomy in accordance with one or more embodiments.
  • Figures 11-1 - 11-3 are a flow diagram illustrating a process for reducing left atrial pressure in accordance with one or more embodiments.
  • Figures 12-1 - 12-3 provide cross-sectional images of cardiac anatomy and certain devices corresponding to the process of Figure 4 according to one or more embodiments.
  • Figure 13 shows a side view of a fluid bypass conduit device implanted in biological tissue in accordance with one or more embodiments.
  • Figure 14 shows a bottom view of distal portions/components of the fluid bypass conduit device shown in Figure 13.
  • Figures 15A and 15B show cross-sectional views of a fluid bypass conduit device having a one-way valve feature in open and closed configurations, respectively, in accordance with one or more embodiments.
  • Figures 16A and 16B show cross-sectional views of a fluid bypass conduit device having a one-way valve feature in open and closed configurations, respectively, in accordance with one or more embodiments.
  • Figures 17A and 17B show cross-sectional views of a fluid bypass conduit device having a one-way valve feature in closed and open configurations, respectively, in accordance with one or more embodiments.
  • Figures 18A and 18B show cross-sectional views of a fluid bypass conduit device having a flow-limiter feature in closed and open configurations, respectively, in accordance with one or more embodiments.
  • the headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed inventive subject matter.
  • the present disclosure relates to systems, devices, and methods for reducing fluid pressure and/or blood flow stagnation in the left atrium and/or associated anatomy by bypassing one or more chambers of the heart.
  • the heart generally comprises a muscular organ having four pumping chambers, wherein the flow of blood between the pumping chambers is at least partially controlled by various heart valves, namely, the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves.
  • the valves may be configured to open and close in response to a pressure gradient present during various stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to a respective region of the heart and/or to associated blood vessels (e.g., pulmonary, aorta, etc.).
  • a pressure gradient present during various stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to a respective region of the heart and/or to associated blood vessels (e.g., pulmonary, aorta, etc.).
  • FIGS 1 and 2 illustrate external perspective and cross-sectional views, respectively, of an example heart 1 having various features/anatomy relevant to certain aspects of the present inventive disclosure.
  • the heart 1 includes four chambers, namely the left ventricle 3, the left atrium 2, the right ventricle 4, and the right atrium 5.
  • a wall of muscle referred to as the septum, separates the left-side chambers from the right-side chambers.
  • an atrial septum wall portion (not shown) separates the left atrium 2 from the right atrium 5
  • a ventricular septum wall portion 17 separates the left ventricle 3 from the right ventricle 4.
  • the inferior tip 18 of the heart 1 is referred to as the apex and is generally located on or near the midclavicular line, in the fifth intercostal space.
  • the heart 1 further includes four valves for aiding the circulation of blood therein.
  • Heart valves may generally comprise a relatively dense fibrous ring, referred to herein as the annulus, as well as a plurality of leaflets or cusps attached to the annulus.
  • the size and position of the leaflets or cusps may be such that when the heart contracts, the resulting increased blood pressure produced within the corresponding heart chamber forces the leaflets at least partially open to allow flow from the heart chamber.
  • the pressure in the heart chamber subsides, the pressure in the subsequent chamber or blood vessel may become dominant and press back against the leaflets. As a result, the leaflets/cusps come in apposition to each other, thereby closing the flow passage.
  • the valves of the heart 1 include the tricuspid valve 8, which separates the right atrium 5 from the right ventricle 4.
  • the tricuspid valve 8 may generally have three cusps or leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole).
  • the valves of the heart 1 further include the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and may be configured to open during systole so that blood may be pumped toward the lungs, and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11.
  • the pulmonary valve 9 generally has three cusps/leaflets, wherein each one may have a crescent-type shape.
  • the heart 1 further includes the mitral valve 6, which generally has two cusps/leaflets and separates the left atrium 2 from the left ventricle 3.
  • the mitral valve 6 may generally be configured to open during diastole so that blood in the left atrium 2 can flow into the left ventricle 3, and advantageously closes during diastole to prevent blood from leaking back into the left atrium 2.
  • the aortic valve (not shown in Figures 1 and 2; see Figure 9) separates the left ventricle 3 from the aorta 12.
  • the aortic valve 7 is configured to open during systole to allow blood leaving the left ventricle 3 to enter the aorta 12, and close during diastole to prevent blood from leaking back into the left ventricle 3.
  • the atrioventricular (i.e., mitral and tricuspid) heart valves are generally associated with a sub-valvular apparatus (not shown), including a collection of chordae tendineae and papillary muscles securing the leaflets of the respective valves to promote and/or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof.
  • the papillary muscles may generally comprise finger-like projections from the ventricle walls.
  • the chordae tendineae generally keep the valve leaflets from opening in the wrong direction, thereby preventing blood to flow back to the left atrium 2.
  • ventricles Surrounding the ventricles (3, 4) are a number of arteries 22 that supply oxygenated blood to the heart muscle and a number of veins 28 that return the blood from the heart muscle to the right atrium 5 via the coronary sinus 16 (see Figure 9), which is a relatively large vein that extends generally around the upper portion of the left ventricle 3 and provides a return conduit for blood returning to the right atrium 5.
  • the left ventricle 3 is the primary pumping chamber of the heart 1.
  • a healthy left ventricle is generally conical or apical in shape in that it is longer (with respect to the mean electrical axis of the heart) than it is wide (with respect to a transverse axis extending between opposing walls of the left ventricle at their widest point) and descends from a base 15 with a decreasing cross-sectional diameter and/or circumference to the point or apex 18.
  • the apical region of the heart can be considered the bottom region of the heart that is within the left and/or right ventricular region but is distal to the mitral 6 and tricuspid 8 valves and disposed toward the tip 18 of the heart.
  • the pumping of blood from the left ventricle 3 is accomplished by a squeezing motion and a twisting or torsional motion.
  • the squeezing motion occurs between the lateral walls of the left ventricle 3 and the septum 17.
  • the twisting motion is a result of contraction of heart muscle fibers that extend in a generally circular or spiral direction around the heart. When these fibers contract, they produce a gradient of angular displacements of the myocardium from the apex 18 to the base 15 about the mean electrical axis of the heart.
  • the resultant force vectors extend at angles from about 30-60 degrees to the flow of blood through the aortic valve and ascending aorta 12.
  • the contraction of the heart 1 is manifested as a counterclockwise rotation of the apex 18 relative to the base 15, when viewed from the apex 18 (i.e., inferior view of the heart 1).
  • the contractions of the heart 1, in connection with the filling volumes of the left atrium 2 and ventricle 3, respectively, can result in relatively high fluid pressures in the left side of the heart at least during certain phase(s) of the cardiac cycle, the results of which are discussed in detail below.
  • the primary roles of the chambers of the left side of the heart are to act as holding chambers for blood returning from the lungs (not shown) and to act as a pump to transport blood to other areas of the heart.
  • the left atrium 2 receives oxygenated blood from the lungs via the pulmonary veins 24, 25 (see Figure 5).
  • the oxygenated blood that is collected from the pulmonary veins 24 in the left atrium 2 enters the left ventricle 3 through the mitral valve 6.
  • the walls of the left atrium 2 are slightly thicker than the walls of the right atrium 5.
  • Deoxygenated blood enters the right atrium 5 through the inferior 16 and superior 19 venae cavae.
  • the right side (i.e., right atrium 5 and right ventricle 4) of the heart then pumps this deoxygenated blood into the pulmonary arteries around the lungs. There, fresh oxygen enters the blood stream, and the blood moves to the left side of the heart via the network of pulmonary veins that ultimately terminate at the left atrium 2, as shown.
  • the right atrial appendage 23 Attached to the right atrium 5 is the right atrial appendage 23, which generally may comprise a pouch-like extension of the pectinate muscles in the walls of the right atrium 5.
  • the right atrial appendage 23 (also referred to as the right auricle) may be considered part of the right atrium 5 in some contexts of the present disclosure.
  • the right atrial appendage 23 has a triangular pocket-type shape and resides inside the pericardial sac on top of the anterior (i.e., frontal) surface of the heart.
  • the right atrial appendage is generally lined internally by pectinate muscles that originate from the terminal crest.
  • the left atrial appendage 26 Attached to the left atrium 2 is the left atrial appendage 26, which generally may comprise a muscular ear shaped pouch.
  • the left atrial appendage 26 (also referred to as the left auricle) is thought to function as a decompression chamber during left ventricular systole and during other periods when left atrial pressure is high.
  • congestive heart failure is a condition associated with the relatively slow movement of blood through the heart and/or body, which can cause the fluid pressure in one or more chambers of the heart to increase, particularly in the left side of the heart. As a result, the heart may not pump sufficient oxygen to meet the body's needs.
  • the various chambers of the heart may respond to pressure increases by stretching to hold more blood to pump through the body or by becoming relatively stiff and/or thickened.
  • the walls of the heart can eventually weaken and become unable to pump as efficiently.
  • the kidneys may respond to cardiac inefficiency by causing the body to retain fluid. Fluid build-up in arms, legs, ankles, feet, lungs, and/or other organs can cause the body to become congested, which is referred to as congestive heart failure.
  • left atrial pressure may be relatively highly correlated with risk of congestive heart failure.
  • Embodiments of the present disclosure can serve to treat and/or prevent congestive heart failure through reduction in left atrial pressure in patients suffering from high left atrial pressure.
  • increases in ventricular filling pressures associated with diastolic and/or systolic heart failure can occur prior to the occurrence of symptoms that lead to hospitalization.
  • cardiac pressure indicators may present weeks prior to hospitalization in some patients. Therefore, reduction in left atrial and/or ventricular pressure in accordance with embodiments of the present disclosure may advantageously be implemented as a preventative measure to reduce risks of hospitalization and/or the onset of heart failure.
  • Dyspnea represents a cardiac pressure indicator characterized by shortness of breath or the feeling that one cannot breathe well enough. Dyspnea may result from elevated atrial pressure, which may cause fluid buildup in the lungs from pressure back-up. Therefore, it may be desirable to implement certain left atrial pressure reduction solutions presented herein in response to dyspnea symptoms. Additionally or alternatively, left atrial pressure reduction in accordance with embodiments or the present disclosure may be implemented prior to manifestation of dyspnea symptoms and/or other symptoms/complications through direct and/or indirect pressure (e.g., left atrial pressure) monitoring and/or intervention.
  • direct and/or indirect pressure e.g., left atrial pressure
  • left atrial pressure monitoring may be implemented using one or more sensors implanted or disposed in one or more chambers of the heart, such as within the left atrium.
  • left atrial pressure may be derived or inferred through measurement of other chambers or vessels of the heart, which may serve as surrogates of left atrial pressure.
  • measurements of pressure in one or more of the right atrium, right ventricle, pulmonary artery, and/or pulmonary artery wedge may indicate elevated left atrial pressure.
  • thrombus i.e., blood clot, embolus
  • Thrombus formation in the left atrial appendage can cause stroke in situations where the thrombus causes vasculature blockage in the brain, causing brain ischemia.
  • the left atrial appendage 26 can generally be formed of a relatively long, tubular and/or hooked structure that has a narrow junction with the venous region of the atrium 2.
  • the left atrial appendage 26 is disposed on the left cardiac border between the left ventricle 2 and pulmonary outflow tract 11, as shown.
  • the junction of the left atrial appendage 26 the atrium proper 2 may generally not be marked either externally or internally by a crest or groove.
  • Both the right 23 and left 26 atrial appendages can be trabeculated, with muscle bars (i.e., pectinate muscles) running generally parallel to each other giving a comb-like appearance (hence termed pectinate muscles).
  • muscle bars i.e., pectinate muscles
  • pectinate muscles running generally parallel to each other giving a comb-like appearance
  • the left atrial appendage 26 may have a volume between about 1-20 ml, and the size of the orifice of the left atrial appendage 26 can have a minimum diameter of about 5-27 mm and a maximum diameter of about 10-40 mm.
  • the length of the left atrial appendage can range from about 15-50 mm.
  • the left atrial appendage 26 generally lies within the confines of the relatively immobile pericardium and is closely related in its superior aspect to the pulmonary artery 11 and inferiorly to the free wall of the left ventricle 2.
  • the left atrial appendage 26 may shorten to a greater extent than the rest of the left atrium 2 and has a distinct pattern of contraction. It should be appreciated that the size and shape of the left atrial appendage 26 can vary greatly from person to person.
  • the relevant flow cycle may begin with a phase of forward flow (i.e., out of the appendage) occurring soon after the start of transmitral flow in the early part of the diastolic phase, followed by a short phase of backward flow (i.e., into the appendage).
  • a further phase of forward flow owing to contraction of the appendage may occur coincidentally with atrial systole, followed by another phase of backward flow, which may be caused at least in part by elasticity of the appendage.
  • the left atrial appendage 26 is relatively commonly associated with thrombus formation, particularly in patients with non-valvar atrial fibrillation.
  • the risk of thrombus formation in the left atrial appendage 26 can be based at least in part on stagnation within trabeculated pouch-type regions of the left atrial appendage. Intra-atrial thrombi formation risk may also be relatively high in patients with atrial flutter.
  • the left atrial appendage 26 contracts with the left atrium and acts as a reservoir for blood flowing through the atrium 2.
  • the contractions of the left atrium 2 and the right atrium 5 are not properly synchronized with the contractions of the left ventricle and the right ventricle.
  • blood may not be fully ejected from the left atrial appendage and can pool and become stagnant.
  • the trabeculated structure of the left atrial appendage can provide flow resistant voids where blood is more likely to pool. This pooled blood may result in blood clot formation in the left atrial appendage. If these blood clots dislodge, they may form an embolism, which can result in disability and even death through occlusion of cerebral and peripheral vasculature.
  • Various solutions for reducing blood flow stagnation in the left atrial appendage can include occlusion of the left atrial appendage and remodeling or dilation of the left atrial appendage to increase blood flow.
  • occluding the left atrial appendage can be undesirable for a variety of reasons.
  • the left atrial appendage can serve as a source of important hormones.
  • the geometry of the left atrial appendage varies from person to person. Therefore, occluding the ostium/orifice of the left atrial appendage with an implant suitable for a particular patient can be difficult.
  • some occlusion devices may be suited for mounting or securing to tissue surrounding the left atrial appendage.
  • tissue surrounding the left atrial appendage is relatively thin, implanting such an occlusion device may increase the risk of rupture and pericardial effusion. Furthermore, occlusion of the left atrial appendage can frustrate the ability of the appendage to act as a compliance chamber to help to regulate blood pressure in the left atrium. In view of the considerations described above, it may generally be desirable to implement blood flow stagnation solutions that at least partially maintain the flow of blood through the left atrial appendage.
  • Solutions for reducing blood flow stagnation in the left atrial appendage can further include clamping and/or removing the left atrial appendage, such as during a cardiac surgery.
  • clamping and/or removing the left atrial appendage can result in one or more of increase in left atrial pressure, dilation of the left atrium, increase in transmitral and/or pulmonary diastolic flow velocities, reduction in stroke volume, reduction in atrial natriuretic peptide secretion/production and/or other adverse hormonal effects, and/or reduction in atrial compliance.
  • the present disclosure relates to systems, devices, and methods for increasing blood flow in the left atrial appendage while maintaining and/or increasing blood flow in the left atrial appendage, thereby at least partially obviating and/or reducing the risk of certain of the outlined drawbacks associated with certain other solutions.
  • embodiments of the present disclosure may increase blood flow in the right atrium and reduce risk of thrombus formation therein.
  • Embodiments of the present disclosure may be initiated and/or implanted in response to determined blood flow and/or other physiological or anatomical condition(s) in the left atrium.
  • transesophageal echocardiography or other imaging modality can be used to determine the size, shape, flow patterns, and/or content of the left atrial appendage.
  • the present disclosure relates to systems, devices, and methods for treating patients suffering from heart failure or risk of heart failure due to elevated left atrial pressure and/or risk of stroke due to embolism formation in the left or right atrial appendage.
  • left atrial pressure and/or blood stagnation in the left atrial appendage can advantageously be decreased, thereby reducing risk of further injury to the patient due to elevated pressure conditions and/or embolism formation.
  • blood flow is shunted to the right atrial appendage or other portion of the right atrium.
  • pressure elevation in the left atrium may be correlated with certain heart failure conditions, as well as pulmonary congestion.
  • Various medical conditions can lead to elevated left atrial pressure, including diastolic heart failure, systolic dysfunction of the left ventricle, and valve disease.
  • HFpEF preserved ejection fraction
  • HFrEF heart failure with reduced ejection fraction
  • These conditions can benefit from a reduction in left atrial pressure, which in turn generally reduces the systolic preload on the left ventricle.
  • Reduction in left atrial pressure can also advantageously relieve pressure on the pulmonary circulation, reducing the risk of pulmonary edema, improving respiration and/or improving patient comfort.
  • Embodiments of the present disclosure advantageously provide systems, devices, and methods for reducing left atrial pressure.
  • left atrial pressure reduction is achieved by shunting an amount of blood flow that otherwise would flow from the left atrium into the left ventricle and be ejected through the aortic valve during systole to the right side of the heart, such as through a conduit or channel that runs from the left side of the heart to the right side of the heart at least partially externally to the heart.
  • fluid bypass conduit devices, and methods of using the same configured to provide such external shunting.
  • cardiac bypass shunting may be implemented internally within one or more chambers of the heart, such as from the left atrium and/or one or more pulmonary veins associated therewith through the interatrial septum wall and/or ventricular septum wall, or via the coronary sinus.
  • embodiments related to internal cardiac fluid bypass shunting are described in detail in US provisional application number 62/860,623, filed on June 12, 2019, entitled FLUID BYPASS CONDUIT FOR LEFT ATRIAL PRESSURE MANAGEMENT, the disclosure of which is hereby incorporated by reference in its entirety.
  • the present disclosure relates to systems, devices, and methods for implementing cardiac bypass shunting external to at least a portion of the heart.
  • the present disclosure relates to fluid bypass conduit devices and/or associated methods for implanting and/or using the same for the purpose of reducing elevated left atrial pressure and/or preventing formation of blood clots in the left and/or right atrial appendages.
  • fluid bypass conduit devices in accordance with the present disclosure can be placed or attached (e.g., sutured or otherwise anchored) at one end of the fluid bypass conduit device to the left atrial appendage or other structure or tissue associated with the left atrium, while an opposite end of the device may be attached/anchored to the right atrial appendage or other tissue or portion of the right atrium or right ventricle.
  • Such fluid bypass conduit devices can comprise at least partially covered, stent-type graft or biological graft conduit frames.
  • Such fluid bypass conduit devices may have any suitable or desirable size (e.g., length and/or diameter).
  • Fluid bypass conduit devices in accordance with one or more embodiments of the present disclosure may be implanted using open-heart surgery (e.g., sternotomy), mini sternotomy, and/or other surgical operations designed to expose one or more portions of the left atrium, right atrium, and/or right ventricle for attaching one more portions of the fluid bypass conduit device thereto.
  • open-heart surgery e.g., sternotomy
  • mini sternotomy e.g., sternotomy
  • other surgical operations designed to expose one or more portions of the left atrium, right atrium, and/or right ventricle for attaching one more portions of the fluid bypass conduit device thereto.
  • FIG. 3 illustrates a heart 1 having a fluid bypass conduit device 70 implanted therein.
  • certain embodiments of the present disclosure advantageously provide for use of bypass conduit devices for connecting/tapping into (e.g., creating a fluid coupling with) the left side of the heart (e.g., the left atrium) from external to the heart, and redirecting a desirable amount of blood flow from the left side of the heart (e.g., left atrium) directly into the right side of the heart (e.g., right atrium or right ventricle) through an external fluid bypass channel formed by the fluid bypass conduit device.
  • Such fluid bypassing can advantageously serve to at least partially reduce or drop the pressure level in the left atrium and/or prevent formation of blood clots in the left atrium, which may be associated with stroke risk in some patients.
  • Methods of implanting fluid bypass conduit devices like the device 70 shown in Figure 3 may involve anchoring a first end 77 (e.g., inflow end) of the fluid bypass conduit devices 70 on, in, and/or through tissue associated with the left atrial appendage 26 of the heart 1.
  • the second end 74 (e.g., outflow end) of the fluid bypass conduit device 70 may be anchored on, in, and/or through tissue associated with the right atrial appendage 23 to provide fluid access from the left atrium 2 into the right side of the heart, such as into the right atrium 5.
  • the fluid bypass conduit device 70 may be configured, shaped, and/or implanted in such that blood that fills the left atrial appendage 26 is channeled at least partially within a lumen or channel 75 of the implant device 70 into the right atrium 5 (e.g., via the right atrial appendage 23), thereby at least partially bypassing the left atrium 2 and/or left ventricle 3.
  • Attachment to the wall 28 of the left atrial appendage 26 may be made in such a way as to allow for blood flow through the wall/surface 28 via the internal channel 75 of the bypass conduit device 70.
  • a hole or opening may be formed in the wall/surface 28, such that the implant bypass channel 75 passes at least partially through the wall/surface 28 or is open thereto.
  • the end(s) of the conduit device 70 may be anchored to the interior wall(s) of the atria.
  • the ends of the implant device 70 may be sutured or anchored to their respective target tissue, such as the exterior and/or interior walls of the left atrium 2 (e.g., at the left atrial appendage) and the right atrium 5 (e.g., at the right atrial appendage), in any suitable or desirable way.
  • Attachment or engagement with external cardiac tissue/surface(s) by a fluid bypass implant device and/or one or more anchor features associated therewith, as described herein, should be understood to relate to engagement or attachment of a fluid bypass implant device and/or associated anchor(s) with any tissue associated with the respective target chamber(s) or vessel(s) of the heart, including any or all of the endocardium, myocardium, epicardium, and/or pericardium.
  • anchoring the fluid bypass implant device 70 in the atria blood flow from the left side of the heart can be channeled within the implant device into the right side of the heart, thereby at least partially bypassing the left side of the heart.
  • the term “associated with” is used herein according to its broad and ordinary meaning.
  • first feature, element, component, device, anatomy, or member is described as being “associated with” a second feature, element, component, device, anatomy, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled to, attached to, connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, anatomy, or member, whether directly or indirectly.
  • the device 70 may couple to more than one target shunting location on a given side of the heart, or more than one fluid bypass conduit implant device may be employed, to provide increased pressure reduction.
  • the device 70 may have a manifold-type configuration, wherein multiple inflow and/or outflow channels of the device are combined together and channeled as desired.
  • the implant device 70 may comprise a tubular, or partially-tubular member or portion 79 having one or more anchors associated with respective ends thereof.
  • the tubular section 79 may advantageously comprise a self-expanding tubular stmcture/frame.
  • the fluid bypass conduit 70 may comprise a fluid-tight covering 76 around at least a portion of the tubular component (e.g., internal frame) 79.
  • the tubular portion 79 does not include an internal frame.
  • One end 77 (e.g., inflow end) of the fluid bypass conduit 70 may be implanted in/on the left atrial appendage 26.
  • An opposite end 74 (e.g., outflow end) of the conduit device 70 may be implanted in/to the right atrial appendage 23 to provide fluid access through the channel 75 of the conduit device 70 from the left atrium 2 into the right atrium 5.
  • the conduit device 70 may be implanted in the posterior and/or medial portion(s) of the right atrium 5, which may be associated with relatively smoother tissue than the right atrial appendage 23. Furthermore, the opposite end 77 of the device 70 may be implanted in the posterior and/or lateral portions of the left atrium 2, which may likewise be associated with relatively smoother tissue than the left atrial appendage 26.
  • the fluid bypass conduit device 70 may act as a bypass channel connecting or tapping from the left atrial appendage 26 to the right atrium 5 through the right atrial appendage 23.
  • the fluid bypass conduit device 70 may act as a bypass channel connecting or tapping from the left atrial appendage 26 to the right atrium 5 through the right atrial appendage 23.
  • the anchor feature(s) 73 associated with the inflow end 77 of the fluid bypass conduit device 70 may be any type of tissue anchor or engagement feature(s).
  • the anchor feature(s) 73 comprise barb- or corkscrew-type tissue- engagement anchors.
  • the anchor feature(s) 73 comprise a structure, such as an expandable structure, having a diameter or other dimension that is wider or greater than a respective dimension of the hole in the target tissue through which blood is shunted.
  • the anchor feature(s) may comprise a flange or other radially- expanding/projecting anchor feature(s).
  • a flange or other radially- projecting anchor feature (72, 78) associated with an end portion of a fluid bypass conduit device in accordance with embodiments of the present disclosure is configured to be sutured or otherwise attached to an outer/extemal surface of the target atrium or ventricle.
  • the anchor feature(s) 72, 78 can be sutured or otherwise anchored to tissue adjacent to the opening in the atrium/ventricle through which blood is shunted.
  • adjacent is used herein according to its broad and ordinary meaning.
  • tissue “adjacent to” an opening in atrial or ventricular tissue through which blood flow is shunted/channeled such description should be understood to refer to tissue near and/or at least partially surrounding an opening within relatively close proximity to the opening, whether on an external or internal surface of the tissue.
  • anchoring features sutured or otherwise anchored to tissue adjacent to an opening in atrial, ventricular, or other cardiac tissue may be within about 1-2 cm of a border or extent of the relevant opening with respect to at least a circumferential/perimeter portion of the opening.
  • a flange or other radially-projecting anchor feature associated with an end portion of a fluid bypass conduit device in accordance with embodiments of the present disclosure is configured to be sutured or otherwise attached to an inner/internal surface of the target atrium or ventricle, such as in a region adjacent to the opening formed in the cardiac tissue for shunting/channeling of blood flow as described herein.
  • the tissue anchor feature(s) 71 associated with the outflow end 74 of the fluid bypass conduit device 70 may be similar or different type(s) of anchor feature(s) than the anchor feature(s) 73 associated with the inflow end 77.
  • the anchor feature(s) 71, 73 may comprise one or more wire and/or coil forms having a width or diameter dimension greater than the shunt opening in the target tissue and configured to prevent the respective end portion of the device 70 from being drawn or pulled through the opening into the chest cavity.
  • the fluid bypass conduit device 70 (or any other embodiment(s) of fluid bypass conduit devices disclosed herein) comprises and/or is associated with a valve device and/or one or more valve-type components.
  • a valve device/component(s) can be disposed in fluid communication with the channel 75, such that the valve can prevent backflow from the right side of the heart to the left side of the heart through the fluid bypass conduit device 70.
  • valve device/component(s) can provide one-way valve functionality that is configured to allow some amount of fluid flow in the illustrated inflow direction while preventing or at least partially preventing/restricting fluid flow from the outflow direction and towards the inflow end 77 of the fluid bypass conduit device 70.
  • Such valve device/component(s) can have any suitable or desirable form or configuration, such as a form or configuration similar to certain transcatheter heart valve devices. That is, a frame of the fluid bypass conduit device 70 may have associated therewith one or more commissure struts for structures to which one or more valve leaflets or flaps may be attached or associated.
  • leaflets/flaps may comprise synthetic and/or biological tissue that is configured to transition between a closed position and an open position.
  • the leaflet(s)/flap(s) may be configured to contact/coapt against one another in the closed configuration.
  • a transcatheter heart valve device can be deployed within the conduit device 70 before or after implantation thereof.
  • Figure 4 illustrates a superior view of the heart 1 and implanted fluid bypass conduit device 70 shown in Figure 3 in accordance with one or more embodiments.
  • the view of Figure 4 shows the external view of the heart and the fluid bypass implant device 70, with the device 70 implanted in the left 26 and right 23 atrial appendages, as in Figure 3.
  • the fluid bypass implant device 70 may include flange features 72, 78 that can be sutured, stapled, or otherwise secured to the surfaces 22, 28 of the left and right atria, respectively.
  • the conduit device 70 can be implanted in a manner wherein the conduit portion thereof passes in front of the pulmonary artery 11 external to the heart/atria, and may be in at least partial contact with the pulmonary artery 11.
  • Fluid bypass conduit devices in accordance with embodiments of the present disclosure may be implanted external to the heart in any suitable or desirable configuration designed to allow for movement of blood from the left side of the heart to the right side of the heart at least partially externally to the heart and/or one or more chambers thereof.
  • the term “external to the heart” is used herein according to its broad and ordinary meaning, and may refer to any device, anatomy, and/or other member or component that is disposed or positioned at least partially external to one or more of the outer surfaces of the left atrium, right atrium, left ventricle, and/or right ventricle within the chest cavity.
  • devices disclosed herein as being implanted “external to the heart,” or “to the exterior of’ a chamber or vessel of the heart may refer to devices that are implanted in such a way as to form and/or at least partially cover an aperture in an exterior (e.g., pericardium, epicardium, and/or myocardium) wall of the heart such that some amount of fluid disposed in a chamber/vessel associated with the wall to which the implant device is implanted may be permitted to exit the respective chamber/vessel into the implant device.
  • an exterior e.g., pericardium, epicardium, and/or myocardium
  • an implant device implanted external to the left atrium and/or to the exterior surface of the left atrium may be attached or fixed (e.g., sutured or otherwise anchored) to the pericardial/epicardial tissue and/or the interior wall of the left atrium.
  • FIG. 5 illustrates a heart 1 having a fluid bypass conduit device 80 implanted thereto in accordance with one or more embodiments of the present disclosure.
  • certain embodiments of the present disclosure advantageously provide for use of bypass conduit devices for connecting/tapping-into the left side of the heart (e.g., the left atrium) from external to the heart, and redirecting a desirable amount of blood flow from the left side of the heart (e.g., left atrium) directly into the right side of the heart (e.g., right atrium or right ventricle) through an external fluid bypass channel formed by the fluid bypass conduit device.
  • Such fluid bypassing can advantageously serve to at least partially reduce the fluid pressure level in the left atrium.
  • FIG. 3 and 4 show a fluid bypass conduit device implanted in the left and right atrial appendages, which can have certain advantages with respect to preventing embolism formation, as described herein.
  • fluid bypass conduit devices in accordance with embodiments of the present disclosure may be implanted in the posterior and/or medial portions of the right atrium 5 and/or the posterior and/or lateral portions of the left atrium 2 at respective ends of the fluid bypass conduit device.
  • selection of implantation site between an atrial appendage and a more posterior portion of the atrium for an end portion of a fluid bypass conduit device may be based at least in part on the type of tissue associated with respective portions of the exterior atrial tissue.
  • the posterior surface of the right and left atria may be associated with tissue that is relatively smooth compared to the anterior portions thereof.
  • the atrial appendages may comprise relatively rough tissue associated with pectinate muscles, for example.
  • one end of a fluid bypass conduit device may be implanted in an atrial appendage, whereas an opposite end of the device may be implanted in an atrial area outside of the area of the associated atrial appendage.
  • Methods of implanting fluid bypass conduit devices like the device 80 shown in Figure 5 may involve anchoring a first end 87 (e.g., inflow end) of the fluid bypass conduit devices 80 on, in, and/or through tissue associated with the left atrium 2 of the heart 1 in an area outside of the left atrial appendage.
  • the second end 84 (e.g., outflow end) of the fluid bypass conduit device 80 may be anchored on, in, and/or through tissue associated with the right atrium 5 to provide fluid access from the left atrium 2 into the right side of the heart.
  • the fluid bypass conduit device 80 may be configured and/or shaped such that, when implanted as shown, at least a portion of the blood that occupies the left atrium is channeled within a lumen or channel 85 of the implant device 80 into the right atrium 5, thereby at least partially bypassing the left ventricle 3.
  • Attachment to the wall 38 of the left atrium 2 may be made in such a way as to allow for blood flow through the wall/surface 38 via the internal channel 85 of the bypass conduit device 80.
  • a hole or opening may be formed in the wall/surface 38, such that the implant bypass channel 85 passes at least partially through the wall/surface 28.
  • the end(s) of the conduit device 80 may be anchored to the interior wall(s) of the atria.
  • the ends of the implant device 80 may be sutured or anchored to their respective target tissue, such as the exterior and/or interior walls of the left atrium 2 and the right atrium 5, in any suitable or desirable way.
  • Attachment or engagement with external cardiac tissue/surface(s) by a fluid bypass implant device and/or one or more anchor features associated therewith, as described herein, should be understood to relate to engagement or attachment of a fluid bypass implant device and/or associated anchor(s) with any tissue associated with the respective target chamber(s) or vessel(s) of the heart, including any or all of the endocardium, myocardium, epicardium, and/or pericardium.
  • the fluid bypass conduit devices may couple to more than one target shunting location on a given side of the heart, or more than one fluid bypass conduit implant device may be employed, to provide increased and/or desired degrees of pressure reduction.
  • the device 80 may have a manifold-type configuration, wherein multiple inflow and/or outflow channels of the device are combined together and channeled as desired.
  • the implant device 80 may comprise a tubular, or partially-tubular, member or portion 89 having one or more anchors associated with respective ends thereof.
  • the tubular section 89 may comprise a self-expanding tubular structure/frame in some embodiments.
  • the fluid bypass conduit 80 may comprise a fluid-tight covering 86 around at least a portion of the tubular component (e.g., internal frame/stmcture) 89.
  • the tubular portion 89 does not include an internal frame, or may include an external conduit frame/structure.
  • the fluid bypass conduit device 80 may act as a bypass channel connecting or tapping from the left atrium 2 to the right atrium 5.
  • the anchor feature(s) 83 associated with the inflow end 87 of the fluid bypass conduit device 80 may be any type of tissue anchor or engagement feature(s).
  • the anchor feature(s) 83 comprise barb- or corkscrew-type tissue- engagement anchors.
  • the anchor feature(s) 83 comprise a structure, such as an expandable structure, having a diameter or other dimension that is wider or greater than a respective dimension of the hole in the target tissue through which blood is shunted.
  • the anchor feature(s) may comprise a flange or other radially- expanding/projecting anchor feature(s).
  • a flange or other radially- projecting anchor feature (82, 88) associated with an end portion of a fluid bypass conduit device in accordance with embodiments of the present disclosure is configured to be sutured or otherwise attached to an outer/extemal surface of the target atrium or ventricle. Additionally or alternatively, a flange or other radially-projecting anchor feature associated with an end portion of a fluid bypass conduit device in accordance with embodiments of the present disclosure can be configured to be sutured or otherwise attached to an inner/intemal surface of the target atrium or ventricle.
  • the tissue anchor feature(s) 81 associated with the outflow end 84 of the fluid bypass conduit device 80 may be similar or different type(s) of anchor feature(s) than the anchor feature(s) 83 associated with the inflow end 87.
  • the anchor feature(s) 81, 83 may comprise one or more expandable wire and/or coil forms having a width or diameter dimension greater than the shunt opening in the target tissue and configured to prevent the respective end portion of the device 80 from being drawn or pulled through the opening into the chest cavity.
  • Figure 6 illustrates a superior view of the heart 1 and implanted fluid bypass conduit device 80 shown in Figure 5 in accordance with one or more embodiments.
  • the view of Figure 6 shows the external view of the heart 1 and the fluid bypass implant device 80, with the device 80 implanted in the posterior regions of the left 2 and right 5 atria, as in Figure 5.
  • the fluid bypass implant device 80 may include flange features 82, 88 that can be sutured, stapled, or otherwise secured to the surfaces 22, 28 of the left and right atria, respectively.
  • the conduit device 80 can be implanted in a manner wherein the conduit portion thereof passes in front of and/or across the pulmonary artery 11 and/or ascending aorta 12 external to the heart/atria, and may be in at least partial contact with the pulmonary artery 11 and/or aorta 12.
  • FIG. 3-6 show fluid bypass conduit devices implanted in the right atrium and right atrial appendage at the outflow end of the conduit devices.
  • fluid bypass conduit devices in accordance with embodiments of the present disclosure may be implanted in the right ventricle at the outflow end of the fluid bypass conduit devices in some implementations.
  • Figure 7 shows a fluid bypass conduit device 90 implanted at an inflow end thereof in the left atrium 2 and/or left atrial appendage 26 associated therewith.
  • Methods of implanting fluid bypass conduit devices like the device 90 shown in Figure 7 may involve anchoring a first end 97 (e.g., inflow end) of the fluid bypass conduit devices 90 on, in, and/or through tissue associated with the left atrium 2 of the heart 1, such as in an area inside or outside of the left atrial appendage 26.
  • the second end 94 e.g., outflow end
  • the fluid bypass conduit device 90 may be anchored on, in, and/or through tissue associated with the right ventricle 4 to provide fluid access from the left atrium 2 into the right side of the heart.
  • the fluid bypass conduit device 90 may be configured and/or shaped such that at least a portion of the blood that occupies the left atrium is channeled within a lumen or channel of the implant device 90 into the right ventricle 4, thereby at least partially bypassing the left ventricle 3.
  • the ends of the implant device 90 may be sutured or anchored to their respective target tissue, such as the exterior and/or interior walls of the left atrium 2 and the right ventricle 4, in any suitable or desirable way, as described in detail herein.
  • the implant device 90 may comprise a tubular, or partially-tubular, member or portion 99 having one or more anchors associated with respective ends thereof.
  • the tubular section 99 may advantageously comprise a self expanding tubular frame/structure in some embodiments.
  • the fluid bypass conduit 90 may comprise a fluid-tight covering 96 around at least a portion of the tubular component (e.g., internal frame) 99.
  • the tubular portion 99 does not include an internal frame/structure.
  • the fluid bypass conduit device 90 may act as a bypass channel connecting or tapping from the left atrium 2 to the right ventricle 4.
  • the anchor feature(s) associated with the inflow end 97 of the fluid bypass conduit device 90 may be any type of tissue anchor or engagement feature(s).
  • the anchor feature(s) comprise barb- or corkscrew-type tissue-engagement anchors.
  • the anchor feature(s) comprise a structure, such as an expandable structure, having a diameter or other dimension that is wider or greater than a respective dimension of the opening/hole in the target tissue through which blood is shunted.
  • the anchor feature(s) may comprise a flange or other radially-expanding anchor feature(s).
  • a flange or other radially-projecting anchor feature (92, 98) associated with an end portion of a fluid bypass conduit device in accordance with embodiments of the present disclosure is configured to be sutured or otherwise attached to an outer/external surface of the target atrium or ventricle. Additionally or alternatively, a flange or other radially-projecting anchor feature associated with an end portion of a fluid bypass conduit device in accordance with embodiments of the present disclosure is configured to be sutured or otherwise attached to an inner/internal surface of the target atrium or ventricle.
  • the tissue anchor feature(s) associated with the outflow end 94 of the fluid bypass conduit device 90 may be similar or different type(s) of anchor feature(s) than the anchor feature(s) associated with the inflow end 97.
  • the anchor feature(s) 91, 93 may comprise one or more wire and/or coil forms having a width or diameter dimension greater than the shunt opening in the target tissue and configured to prevent the respective end portion of the device 90 from being drawn or pulled through the opening into the chest cavity.
  • Figure 8 illustrates an embodiment of a fluid bypass conduit device 30 in accordance with one or more embodiments of the present disclosure.
  • the conduit device 30 may be an expandable or non-expandable implant device in accordance with embodiments disclosed herein.
  • the fluid bypass conduit device 30 comprises a self expanding stent or frame component 37, which may be shaped and configured to form a conduit, such as a cylindrical-cross-sectional conduit, as described herein, or conduit having any other suitable or desirable cross-sectional shape.
  • a fluid bypass conduit device may be balloon-expandable or may not require expansion after deployment (e.g., from a delivery system).
  • the fluid bypass conduit device is not collapsible and/or expandable.
  • the implant device 30 may be implanted in a substantially deployed/expanded configuration in connection with a surgical or minimally-invasive (e.g., transthoracic) procedure or access to the heart of a patient.
  • Opposite ends 32, 34 of the conduit portion of the device 30 can be coupled to and/or otherwise associated with one or more anchor components 31, 33, respectively.
  • the image of Figure 8 shows barb-/hook-type tissue anchors 31, 33.
  • any types of anchors may be utilized in connection with fluid bypass conduit devices in accordance with embodiments of the present disclosure.
  • the ends of the conduit device 30 may have flange or other-type anchor features 38, 39, which may be configured to be sutured or otherwise attached to the exterior and/or interior of a heart, as described herein.
  • the flange-type features 38, 39 can be fully circumferential or may be disposed around only a portion of the circumference or outer perimeter of the conduit device 30.
  • the flange features are configured to be disposed within a chamber/vessel of a heart and help prevent withdrawal therefrom of the end(s) of the device 30.
  • the anchor features 38, 39 can advantageously project radially from the conduit such that they have a dimension (e.g., width, diameter, etc.) that is greater than a width/diameter of the conduit portion of the device 30.
  • an single end of a fluid bypass conduit device may be implanted in fluid communication with more than one chamber/vessel and/or more than one portion of a chamber/vessel.
  • such implementations may utilize two separate conduit devices, or may utilize a single conduit device having a plurality of distal conduit openings/inlets for implantation in more than one location at either of the inflow or outflow ends of the device/assembly in order to provide the desired pressure -reduction functionality.
  • tissue anchors 31, 33 shown in Figure 8, as well as those described in connection with other embodiments of the present disclosure, may be any suitable or desirable types of tissue anchors.
  • a tissue anchor associated with a fluid bypass conduit device comprises a pre-shaped wireform, such as a loop, coil, spiral, or the like, which may be configured to assume a relatively wide tissue anchor profile once deployed.
  • tissue anchors that may be used include, but are not limited to, tension-fit or resistance-fit tissue anchors, such as stents or the like, barb-type tissue anchors, which may incorporate tip features configured to resist withdrawal of the anchor tip(s) from tissue in which it is embedded following embedding, corkscrew-type tissue anchors, and/or other types of tissue anchors that may or may not be known in the art.
  • the fluid bypass conduit device 30 may advantageously be dimensioned to have a length L sufficient to traverse the distance from the target inflow implantation site (e.g., the left atrium and/or left atrial appendage) to the target outflow implantation site (e.g., right atrium, right atrial appendage, and/or right ventricle).
  • the fluid bypass conduit device 30 may have a length of approximately 3-10 cm.
  • the conduit device 30 is configured to have a variable length, wherein the length of the conduit may adjust or flex in response to contraction of the heart.
  • the fluid bypass conduit device 30 may advantageously be configured with self expansion characteristics allowing for expansion and/or contraction of the cardiac anatomy being absorbed by the frame 37 and/or other components of the device 30.
  • the fluid bypass conduit device 30 advantageously includes a covering 36, which may be disposed within or without the frame 37, and may be at least partially fluid- tight, to thereby facilitate funneling or channeling of blood flow through the medial portion 35 of the conduit device 30.
  • the fluid bypass conduit device 30 may comprise a covered stent or graft structure.
  • the device 30 may be covered with thin PTFE material, or other material or biological tissue.
  • the anchor(s) 31, 33 of the inflow and outflow end may be anchored/implanted in the atrial or ventricular tissue in any suitable or desirable way.
  • fluid bypass conduit devices in accordance with the present disclosure may be coupled to any chamber, vessel, or anatomy associated with the left and/or right side(s) of the heart.
  • a fluid bypass conduit device is coupled from the left atrium or other chamber or vessel associated with the left side of the heart to the right ventricle, as shown in Figure 7, as opposed to the right atrium (e.g. right atrial appendage).
  • the fluid bypass conduit device 30 can inhibit undesirable expansion or dilation of the atria once it is implanted in accordance with some implementations. That is, the fluid bypass conduit device 30 can advantageously serve to prevent the left atrium 2 and/or right atrium 5 from dilating or stretching due to undesirable enlargement.
  • the bypass fluid conduit 30 e.g., a metal frame thereof and/or other component of the bypass fluid conduit
  • Figure 9 shows a top-down view of the left and right atria of a heart 11, wherein a fluid bypass conduit device 40 is coupled between the left 2 and right 5 atria to provide left-to-right fluid bypass shunting as described in detail herein.
  • the conduit device 40 shown in Figure 9 includes various features that may be incorporated in any of the disclosed embodiments.
  • the conduit device 40 includes an accordion-type shock absorber feature 48, which may be part of, or incorporated in, one or more of an internal frame and/or covering 46 of the conduit device 40, as described in detail herein.
  • the feature 48 may comprise a plurality of pleated layers that may be integrated with the covering 46 and allow for longitudinal expansion and contraction of the conduit device 40.
  • the shock- absorber feature 48 may advantageously be compressible to accommodate reduction in longitudinal length of the conduit in connection with contraction of the atria and/or other chamber(s) of the heart 11.
  • tissue-anchoring components or portions of a fluid bypass conduit device in accordance with embodiments of the present disclosure may comprise any suitable or desirable form or mechanism, including any known tissue-anchoring devices or mechanisms.
  • the conduit device 40 advantageously includes an expandable anchor 41 associated with an outflow 42 (and/or inflow 44) end portion of the conduit device 40.
  • the expandable anchor 41 may have a diameter d in an expanded configuration that is greater than one or both of a diameter of the opening 85 in the atrial wall and the diameter of the conduit device 40, such that the anchor 41 retains the conduit device 40 in place and prevents the proximal end 42 of the conduit device 40 from being pulled through the opening 85 in the atrial wall into the chest cavity.
  • One or both ends (such as the inflow end 44, as shown) of the conduit device 40 may be associated with a radially-projecting flange-type anchor 43, which may be configured to project within the target chamber- vessel in a manner as to resist withdrawal of the end 44 of the device 40 through the opening 86.
  • the inflow and/or outflow end(s) of the fluid bypass conduit device 40 may be sutured to the atrial (and/or ventricular) anatomy, such as to the outer pericardium and/or epicardium of the atria at the end(s) of the device 40 and/or at one or more medial portions of the conduit portion of the device 40.
  • flanged features of the conduit device, or other extension/projection features provide a radial surface for suturing.
  • the flange feature(s) 43 associated with the inflow and/or outflow ends of the fluid bypass conduit device 40 may be sutured to the inner wall of one or more of the atria, which may provide improved retention characteristics to facilitate maintenance of the end(s) of the fluid bypass conduit device 40 in attachment with the atrium/atria for an extended period of time due to the function of the flanged features as providing force against the inner atrial wall(s) to thereby further inhibit the end(s) from becoming withdrawn out of the chamber(s).
  • FIG 10 is a flow diagram illustrating a process 60 for treating a patient.
  • the process 60 may be suitable for treating a patient to reduce left atrial pressure and/or risk of embolism formation due to blood stagnation in an atrial appendage of the patient.
  • the process 60 can be implemented to bypass blood flow outside of the heart across from the left side of the heart to the right side thereof (e.g., left atrium to right atrium) to at least partially neutralize or reduce elevated left atrial pressure, which can be linked to heart failure and/or risk thereof, as described in detail above.
  • such shunting of blood flow from the left side of the heart to the right side of the heart can advantageously reduce the risk of blood clot formation in the left atrial appendage and/or the right atrial appendage.
  • shunting through the fluid bypass conduit device can advantageously increase blood flow within and/or through the left atrial appendage, thereby inhibiting the collection of relatively stagnant blood in the left atrial appendage and decreasing the risk of blood clot formation in the left atrial appendage, which can lead to stroke and/or other health complications as described in detail above.
  • the process 60 involves accessing the exterior of the heart of a patient, such as one or more of the atria and/or ventricles thereof.
  • accessing the exterior of the heart may involve accessing a chest cavity of the patient.
  • Access to the exterior of the heart may be made via a transthoracic procedure, such as a mini sternotomy procedure, which may advantageously be implemented to expose at least a portion of the left and right atrial appendages.
  • an open-chest procedure may be implemented to provide the desired heart access.
  • the process involves forming separate openings in the chest wall of the patient for access to the left and right atria, respectively.
  • the process involves removing at least a portion of one or more ribs in order to expose the target implantation site(s).
  • opening the rib cage may be implemented to provide better access to the target cardiac anatomy.
  • the process 60 involves forming an opening in an exterior wall of the left atrium at a target implantation site, such as in a left atrial appendage region of the left atrium.
  • the opening may advantageously traverse the wall of the atrium through to the interior thereof.
  • the process 60 involves anchoring a first end of a fluid bypass conduit device over and/or through the opening formed in the left atrium.
  • forming the opening in the left atrium and anchoring the fluid bypass conduit device thereto may be performed as part of a single step.
  • forming the opening in the left atrium may be performed before or after anchoring of the first end of the fluid bypass implant device to the left atrium.
  • anchoring an end of the fluid bypass conduit device in accordance with one or more steps of the process 60 can involve suturing a flange and/or other anchoring feature(s) associated with the fluid bypass conduit device to the target tissue, either externally or internally.
  • a flange associated with a cover of the fluid bypass conduit device may be sutured to the pericardium and/or epicardium of the atrial or ventricular region and/or to an internal surface thereof, as described in detail herein.
  • the process 60 involves forming an opening in an exterior wall of the right atrium or right ventricle at a target implantation site, such as in a right atrial appendage region of the right atrium.
  • the opening may advantageously traverse the wall of the atrium or ventricle through to the interior thereof.
  • the process 60 involves anchoring a second end of the fluid bypass conduit device over and/or through the opening formed in the right atrium or ventricle.
  • forming the opening in the right side of the heart and anchoring the fluid bypass conduit device thereto may be performed as part of a single step.
  • the opening in the right atrium or ventricle may be performed before or after anchoring of the second end of the fluid bypass implant device to the right atrium or ventricle.
  • the process steps 62-68 can advantageously provide fluid access from the left atrium into the right side of the heart, such as into the right atrium.
  • the fluid bypass conduit device may be delivered and/or implanted using a catheter-based delivery system.
  • the entire fluid bypass conduit device and/or associated tissue anchoring features may be delivered to the target implantation site within one or more delivery catheters or sheaths.
  • the process 60 may be implemented in response to any physiological condition or event.
  • the process 60 may be implemented in response to development and/or occurrence of atrial fibrillation the patient, which can increase the risk of blood clot formation in, for example, the left atrial appendage and/or other cardiac vessel/chamber.
  • the process 60 may be aided at least in part by electromagnetic and/or sonic imaging or may be performed without the aid of imaging technology. Visual assistance using any suitable or desirable type of imaging modality may be implemented in accordance with embodiments of the present disclosure.
  • Figure 11 illustrates another process 100 for shunting blood flow from a left atrial appendage or other chamber or vessel associated with the left side of the heart to the right atrial appendage or other chamber or vessel associated with the right side of the heart in accordance with one or more embodiments of the present disclosure.
  • Figure 12 shows images of cardiac anatomy corresponding to the various operations of the process 100 of Figure 11.
  • the process 100 involves advancing a delivery system for a fluid bypass conduit device 50 in accordance with embodiments the present disclosure to a left atrial appendage 28 of a heart, as shown in image 201 of Figure 12.
  • the delivery system can include the fluid bypass conduit device 50, as well as a tissue puncturing/opening device or system including a punctured tip portion 91 and/or shaft portion 93.
  • the operation associated with block 102 of the process 100 can involve, as shown in image 201, advancing a distal portion 54 of the fluid bypass conduit device 50 into proximity with the left atrial appendage 28.
  • the tissue-puncturing point or component 91 may comprise a pointed needle or blade member or form. That is, although a conical pointed form 91 is shown in Figure 12, it should be understood that any type of tissue-puncturing or -opening structure or device may be implemented in accordance with embodiments of the present disclosure for creating an opening in the left atrial appendage 28 and/or other chamber or vessel.
  • the process 100 involves puncturing tissue associated with the left atrial appendage 28 and inserting at least a portion of the tissue-puncturing component 91 and/or distal portion 54 of the fluid bypass conduit device 50 into the target chamber/vessel.
  • the process 100 may involve inserting a distal anchoring feature 59 associated with the fluid bypass conduit device 50 into the target chamber/vessel 28.
  • the distal anchoring feature 59 may comprise, for example, a flange feature as described in detail herein.
  • Such flange feature 59 may be inserted into the left atrial appendage 28 in an at least partially compressed state or configuration, such that the flange can be radially expanded to provide anchoring support.
  • the flange feature 59 may be folded into a generally tubular/cylindrical form, as shown in images 201 and 203.
  • images 201 and 203 the remainder of the description of Figures 11 and 12 is described and illustrated with respect to the left atrial appendage 28 and right atrial appendage 22, it should be understood that such description may involve shunting from any suitable or desirable chamber or vessel of the cardiac anatomy.
  • the process 100 involves withdrawing the puncture element 91 from the target chamber 28 proximally to allow blood from the left atrial appendage 28 to enter a portion of the medial conduit 55 of the fluid bypass conduit device 50.
  • the operation associated with block 106 may further comprise or involve expanding, or allowing to expand, the anchor feature 59 associated with the distal end 54 of the fluid bypass conduit device 50.
  • proximally withdrawing the puncture component 91 and/or shaft component 93 may serve to open a space in the conduit portion 50 of the fluid bypass conduit device 50 into which blood may naturally flow.
  • the left atrial appendage 28 may generally be associated with relatively high fluid pressure levels, such that such pressure in the left atrium and/or left atrial appendage may cause blood disposed therein to flow into the conduit 55 of the fluid bypass conduit device 50.
  • the puncture component 91 and/or associated shaft or pusher component 93 may advantageously serve to block fluid flow from continuing to flow proximally within the conduit 55 past a point where the puncture component 91 and/or shaft 93 are disposed, which may advantageously prevent blood loss during implantation of the fluid bypass conduit device 50.
  • the fluid bypass conduit device 50 may include a valve or other feature(s) configured to at least partially constrict or block fluid flow into the medial conduit 55 in some manner.
  • the puncture component 91 and shaft component 93 are integrated.
  • the process 100 involves crimping, clamping, or otherwise collapsing the conduit 50 at an axial point 51 in order to stop or impede blood flow through the conduit 50.
  • crimping/clamping may be implemented on a temporary basis, such as during a period of the implantation process, as a means to prevent undesirable blood loss through the conduit 50 during the implantation process.
  • Any suitable or desirable crimping or clamping device or mechanism may be implemented to form the fluid blockage 51, such as a forceps tool 95 or the like.
  • the process 100 may involve further withdrawing the puncture component 91 and/or associated shaft component 93.
  • the puncture component 91 and/or shaft component 93 may be fully withdrawn from the conduit portion 55 of the fluid bypass conduit device 50, as shown for reference in image 209.
  • the conduit portion 55 of the fluid bypass conduit device 50 may include a distal portion 57, in which fluid from the left atrium and/or left atrial appendage may flow and/or be filled therein, and a proximal portion 53, which may not have blood present substantially therein. That is, in the state associated with the image 207 and/or operation 108, blood may not be permitted to freely flow into the proximal portion 53 of the fluid bypass conduit device 50.
  • the process 100 involves using a tool or device 61 to puncture the right atrial appendage 22 and/or form an opening therein.
  • the puncture tool/device 61 may be attached to, integrated with, or otherwise associated with the proximal end 52 of the fluid bypass conduit device 50.
  • the puncture tool or device 61 is the same as the puncture tool or device(s) 91 and/or 93.
  • the proximal end 52 of the fluid bypass conduit device 50 may be associated with an anchoring feature 58, such as a flange-type anchoring feature, or any other suitable or desirable anchoring feature in accordance with embodiments of the present disclosure.
  • the process 100 involves implanting the proximal end portion 52 of the fluid bypass conduit device 50 in the opening formed in the right atrial appendage 22.
  • the process 100 may involve inserting the proximal end portion 52 and/or the anchoring feature 58, which may be inserted in an at least partially compressed or collapsed state (see image 207), into the opening formed in the right atrial appendage 22.
  • the process 100 may further involve expanding, or allowing to expand, the anchor feature 58 within the chamber 22.
  • the anchor feature 58 may automatically or naturally expand or flare outward when deployed from a delivery system in the right atrial appendage 22.
  • FIG. 11 and 12 illustrated and described use of flange-type tissue anchors disposed within respective cardiac chambers, it should be understood that other tissue anchor components may be used or implemented and may be anchored at least partially external to the respective target cardiac chambers and/or to or within tissue walls associated therewith.
  • blood may be permitted to flow into the proximal portion 53 of the fluid bypass conduit device 50 from the right atrium and/or right atrial appendage.
  • the right atrial appendage and/or right atrium may be associated with relatively lower fluid pressure levels compared to the left atrial appendage and/or left atrium. Therefore, in some implementations, the extent to which the proximal portion 53 of the fluid bypass conduit device 50 is filled with blood in connection with the state 211 may be less than that associated with the distal portion 57.
  • the process 100 involves undoing or removing the blockage/clamp 51 from the conduit portion 55 of the fluid bypass conduit device 50 to open fluid communication between the distal portion 57 and the proximal portion 53 of the conduit 55.
  • fluid may be shunted from the higher-pressure left atrial appendage 28 to the lower- pressure right atrial appendage 22 through the conduit portion 55 of the fluid bypass conduit device 50. That is, the internal channel 56 of the conduit 55 may allow blood to flow across the pressure gradient in the direction illustrated in the image 213.
  • the operation at block 114 may further involve withdrawing the delivery system from the patient, to thereby allow the implant device 52 to remain and/or be maintained as implanted in the cardiac anatomy to allow ongoing shunting at least partially external to the heart to provide benefits described in detail herein.
  • Figure 13 illustrates a side view of the fluid bypass conduit device 300 implanted in biological tissue in accordance with one or more embodiments of the present disclosure.
  • the embodiment illustrated in Figure 13 may relate to a multiple- piece/component fluid bypass conduit device in accordance with aspects of the present disclosure.
  • a fluid bypass conduit device may comprise a medial conduit portion or component 305 that is detachable from one or more end portions thereof, referred to herein as “endcaps.”
  • the fluid bypass conduit device 300 may comprise a distal end portion 340 and a proximal end portion 320, each of which may or may not be detachable from the medial conduit portion/component 305.
  • Each of the distal 304 and proximal 302 ends of the medial conduit portion/component 305 may be configured to be connected to a respective one of the distal endcap 340 and/or proximal endcap 320.
  • the end portions 304, 302 of the conduit 305 may comprise features configured to engage with a respective one of the distal 340 and proximal 320 endcaps/portions of the fluid bypass conduit device 300.
  • either or both of the distal 304 and proximal 302 ends of the medial conduit portion/component 305 may comprise threaded features 314 configured to mate or engage with corresponding threaded features of the respective end (e.g., 320, 340).
  • the threaded features 314 associated with the conduit component 305 may be external threading features or preformed internal threading features, wherein a respective and (e.g., 320, 340) may have corresponding externally- (e.g., threads) or intimately- (e.g., thread recess(es)) threaded features configured to mate with the features of the conduit component 305.
  • one or more of the end portions 302, 304 of the conduit device 305 may be configured with snap-engagement feature(s) 312, 313, which may be configured to be inserted and/or locked into the respective endcap component (e.g., 320, 340).
  • snap-type engagement features may comprise one or more extensions, flanges, rims, recesses, and/or the like configured to fit against and/or mate with corresponding features or portions of the respective endcap device (e.g., 320, 340).
  • the endcap components 320, 340 may be configured to be implanted in biological tissue in any suitable or desirable way and/or using any suitable or desirable mechanism and/or features.
  • the endcap components 320, 340 may be implanted and/or implantable in the target biological tissue portions prior to implantation and/or connection of the conduit device 305.
  • a procedure for implanting a fluid bypass conduit device in accordance with embodiments of the present disclosure may involve initially implanting one or more endcap components in the respective biological tissue portions, after which the conduit device 305 may be coupled to the endcaps to provide fluid communication through the endcaps via the conduit portion 305.
  • the endcap devices 320, 340 may be implanted at least partially within a plane of the target biological tissue.
  • the end caps 320, 340 may comprise one or more flange-type or other engagement features 322, 323, which may be configured to engage one or more sides of the biological tissue, as shown in Figure 13.
  • the endcap components 320, 340 may be configured to be secured to the biological tissue on an external surface 307 of the biological tissue and/or an internal surface 309 of the biological tissue.
  • the endcap components may be sutured or otherwise secured to the external surface 307 of biological tissue, or may be disposed entirely within the chamber associated with the internal surface 309, wherein the endcap may or may not be sutured or otherwise secured to the internal surface 309.
  • the endcap components and/or conduit device 305 may advantageously be configured to be locked in the attached configuration shown in Figure 13.
  • Figure 14 shows a bottom view of the endcap components 320, 340 shown in Figure 13 and described above. As shown, one or more of the endcap devices 320, 340 may have associated therewith one-way valve features to at least partially control the flow of fluid through the fluid bypass conduit device 300.
  • valve features associated with one or more of the endcap components 320, 340 can comprise valve leaflets or other features configured to open in one direction (e.g., proximately, as shown in Figure 13), to thereby allow for fluid shunting through the conduit device 305 in the proximal direction, wherein the valve features 360, 365 may be configured to at least partially block or prevent fluid flow in the distal direction (e.g., from the right side of the heart to the left side of the heart).
  • valve leaflets are shown in each of the valves 360, 365, it should be understood that any number or type of valve features or components may be included in the respective endcap devices 320, 340.
  • Figures 13 and 14 show valve features 360, 365 associated with each of the proximal 320 and distal 340 endcap components, respectively, in some embodiments and/or implementations, only one of the endcap components has valve features associated therewith.
  • valve features are illustrated and described as being associated with endcap components, it should be understood that valve features may additionally or alternatively be associated with axial portions of the conduit device 305, at any axial portion or region thereof.
  • the conduit device 305 is configured to penetrate a valve feature of one or more of the endcap components 320, 340 in order to open the valve component(s) and provide fluid connectivity therethrough.
  • the valve features may be configured and designed to prevent fluid from flowing therethrough when the endcap component(s) are implanted in the biological tissue without the conduit device 305 being coupled thereto. Therefore, the valve features 360 and/or 365 may have sufficient fluid retention characteristics to prevent fluid from flowing out of the target cardiac chamber(s) when separately implanted without a coupled conduit device 305.
  • implanting the conduit device 305 in the endcap portions 320 and/or 340 may cause the valve features to be forced open, to thereby create an opening through the endcap components 320 and/or 340, as well as into and through the conduit 305. Therefore, although the valve features 365, 360 are shown as being disposed within the opening of the endcap devices in a manner to allow for the valve components 360, 365 to open and close after coupling of the conduit device 305, in some embodiments, once the conduit device 305 is secured and/or engaged with the respective endcap components 320 and/or 340, such valve features may be at least partially fixed and/or prevented from closing off the conduit path of the conduit device 305.
  • the components 320, 340 are described herein as endcaps, it should be understood that such components may comprise any suitable or desirable appendage adapter structures for coupling to a conduit or associated structure.
  • the proximal endcap component 320 has valve components configured to provide a one-way valve that seals/prevents outflow from the right-side cardiac chamber into the conduit 305, whereas the valve features associated with the distal endcap component 340 may have valve features that allow outflow from the respective cardiac chamber into the conduit pass 305.
  • the conduit device 305 may have any suitable or desirable form and/or component(s).
  • the conduit device 305 may comprise an internal frame, as described in detail herein.
  • the conduit device 305 may comprise a covering 306 configured to maintain a fluid-tight barrier between the inside of the conduit lumen and the external environment.
  • Figures 15A and 15B show cross-sectional views of a fluid bypass conduit device 150 having a one-way valve feature 156 in open and closed configurations, respectively, in accordance with one or more embodiments of the present disclosure.
  • the fluid bypass conduit device 150 may be implanted external to the heart, at least in part, wherein one or more ends of the device 150 are disposed in fluid communication with one or more chambers or vessels of the heart.
  • first 154 and second 152 ends of the conduit device 150 are implanted in fluid communication with the left atrial appendage 26 and right atrial appendage 23, respectively.
  • the fluid bypass conduit device 150 may be configured to act as a bypass tube connecting/tapping from the outside of the heart into, for example, the right and/or left atrial appendages to redirect some amount of blood flow from the left side of the heart into the right side of the heart (e.g., right atrium).
  • Such bypass flow can help to reduce or drop the blood flow and pressure from the left atrium, thereby potentially preventing or reducing the risk of formation of blood clots at the atrial appendage(s) that can result in stroke or other health complications.
  • FIG. 15-18 The various flow- limiting features shown in Figures 15-18 preventing or impeding flow from the right side of the heart to the left side of the heart can help reduce the introduction of deoxygenated blood into the left side of the heart.
  • the devices shown in Figures 15-18 are shown as being implanted in the left and right atrial appendages, it should be understood that such devices may be implanted in any area, chamber, vessel, and/or region of the heart.
  • the fluid bypass conduit device 150 includes a flow-limiting feature 156, which may comprise, for example, a one-way valve feature.
  • the valve feature 156 may be associated with any axial/longitudinal portion of the conduit device 150.
  • the valve 156 may be disposed at any point along the length of the tube 155.
  • the valve feature 156 is disposed at or near the end 154 of the device 150.
  • the valve 156 may advantageously allow for fluid flow in one direction through the tube 155, while preventing or impeding flow in the reverse direction.
  • fluid flow from the left atrial appendage 26 and/or left atrium may be permitted to flow through the valve feature 156, through the tube 155, and out of the end 152 into the rights atrial appendage 23 and/or right atrium, as indicated by the illustrated arrows in Figure 15 A.
  • Figure 15A shows the valve feature 156 as permitting fluid flow in the direction from the left side of the heart to the right side of the heart
  • the device 150 may include a valve feature and/or may be implanted in a manner as to allow fluid flow from the right side of the heart to the left side of the heart and/or prevent or impede fluid flow in the opposite direction.
  • the valve feature 156 may be any type of valve.
  • the valve feature 156 may comprise a plurality of leaflets 157 configured to open in one direction and coapt or otherwise close to prevent fluid flow in the opposite direction.
  • the valve leaflets 157 have certain thickness, length, and/or other characteristics that produce a flow-limiting affect in the direction of flow generally permitted by the valve feature.
  • the valve leaflets 157 may resist/impede fluid flow through the valve 156 in the outflow direction dependent at least in part on the amount of fluid pressure present on the inflow side of the valve 156.
  • the valve 156 may be configured to open only when fluid pressure on the inflow side of the valve exceeds a certain threshold level.
  • the amount of fluid flow permitted through the valve 156 increases gradually (e.g., in a linear, or semi-linear, logarithmic, or other non-linear manner) as the pressure level increases.
  • the characteristics of the valve leaflets 157 may be designed/configured in order to set a pressure threshold above which a desired amount of blood flow may be permitted to flow. The use of a one-way valve with set flow-limiting characteristics can prevent unwanted blood flow to the right side of the heart until the pressure in the left atrium and/or left atrial appendage exceeds the valve limit to allow blood flow therethrough.
  • the valve leaflets 157 may comprise synthetic and/or natural biological tissue material(s).
  • Figures 16A and 16B show cross-sectional views of a fluid bypass conduit device 160 having a one-way valve feature 166 in open and closed configurations, respectively, in accordance with one or more embodiments.
  • the fluid bypass conduit device 160 may be similar in certain respects to the fluid bypass conduit device 150 shown in Figures 15A and 15B and described above.
  • the one-way valve feature 166 of the device 160 may comprise a disc-type valve, wherein a disc feature 167 of the valve 166 is configured to open (e.g., axially translate upward with respect to the orientation shown in Figure 16A) to allow blood flow to flow from under the disc 167, around the disk, and into the tube portion 165 of the device 160.
  • the valve feature 166 may be associated with any axial/longitudinal portion of the conduit device 160.
  • the valve 166 may be disposed at any point along the length of the tube 165.
  • the valve feature 166 is disposed at or near the end 164 of the device 160.
  • the valve 166 may advantageously allow for fluid flow in one direction through the tube 165, while preventing or impeding flow in the reverse direction.
  • fluid flow from the left atrial appendage 26 and/or left atrium may be permitted to flow through the valve feature 166, through the tube 165, and out of the end 162 into the right atrial appendage 23 and/or right atrium, as indicated by the illustrated arrows in Figure 16A.
  • Figure 16A shows the valve feature 166 as permitting fluid flow in the direction from the left side of the heart to the right side of the heart
  • the device 160 may include a valve feature and/or may be implanted in a manner as to allow fluid flow from the right side of the heart to the left and/or prevent or impede the flow in the opposite direction.
  • Axial movement/translation of the disc 167 may be governed and/or permitted by a post feature 163, which may be coupled mechanically and a slidable/movable manner to the structure of the end 164 of the device 160.
  • the post 163 may be fixed to an underside of the disc 167.
  • a spring coil or other tensioning feature may be associated with the post/peg 163, which restricts movement of the disc 167 into the interior of the device 160, thereby serving as a flow-limiter feature. Fluid pressure sufficient to overcome the tension of the spring or other tensioning feature can result in fluid flow in increasing degrees as pressure increases.
  • the disc 167 may be disposed against one or more seat portions 169, which may form an at least partially tapered surface against which the disc 167 may be sealed. With the disc disposed against the seat 169, flow from the left atrial appendage 26 into the tube 165 may be prevented or substantially impeded, as well as backflow from the right atrial appendage 23 into the left atrial appendage 26.
  • the valve 166 may be configured to open only when fluid pressure exceeds a certain threshold level. In some implementations, the amount of fluid flow permitted through the valve 166 increases gradually (e.g., in a linear, semi-linear, logarithmic, or other manner) as the pressure level increases. In some embodiments, the characteristics of the disc 167 and/or disc support 163 (which may have a spring tension feature) may be designed/configured in order to set a pressure threshold above which the desired amount of blood flow may be permitted to flow. The use of a one-way valve with set flow-limiting characteristics can prevent unwanted blood flow to the right side of the heart until the pressure in the left atrium and/or left atrial appendage 26 exceeds the valve limit to allow blood flow therethrough.
  • the valve disc 167 may comprise plastic, metal, and/or material(s).
  • Figures 17A and 17B show cross-sectional views of a fluid bypass conduit device 170 having a one-way valve feature 176 in closed and open configurations, respectively, in accordance with one or more embodiments of the present disclosure.
  • the fluid bypass conduit device 170 may be similar in certain respects to the fluid bypass conduit device 160 shown in Figures 16A and 16B and described above.
  • the one-way valve feature 176 of the device 170 may comprise a disc-type valve, wherein a disc feature 177 of the valve 176 is configured to open (e.g., axially translate downward and to the left with respect to the orientation shown in Figure 17A) to allow blood flow to flow from behind the disc 177, around the disk, and into right atrial appendage 23 from the tube portion 175 of the device 170, as shown in Figure 17B.
  • valve feature 166 is associated with an end/side 164 of the device 160 that is implanted in/to the left side of the heart (e.g., left atrial appendage) at an inflow end of the device 160
  • valve feature 176 of the conduit device 170 may be associated with an end 172 of the device 170 that is implanted in/to the right side of the heart (e.g., right atrial appendage 23) at an outflow end of the device 170.
  • any of the valve features associated with fluid bypass conduit devices of the present disclosure may be positioned, disposed, and/or arranged at any axial portion/region of the conduit device, and may open in any direction, or both directions.
  • the valve 176 may advantageously allow for fluid flow in one direction through the tube 175, while preventing or impeding flow in the reverse direction.
  • fluid flow from the left atrial appendage 26 and/or left atrium may be permitted to flow through tube 175 and the valve feature 176, at least in the presence of fluid pressures beyond a certain threshold, and out of the end 172 into the right atrial appendage 23 and/or right atrium, as indicated by the illustrated arrows in Figure 17B.
  • Figure 17B shows the valve feature 176 as permitting fluid flow in the direction from the left side of the heart to the right side of the heart
  • the device 170 may include a valve feature and/or may be implanted in a manner as to allow fluid flow from the right side of the heart to the left and/or prevent or impede the flow in the opposite direction.
  • Axial movement/translation of the disc 177 may be governed and/or permitted by a post feature 178, which may be coupled mechanically and a slidable/movable manner to the structure of the end 172 of the device 170.
  • the post 178 may be fixed to an underside of the disc 177.
  • a spring coil or other tensioning feature may be associated with the post/peg 173, which restricts movement of the disc 177 into the open configuration, thereby serving as a flow-limiter feature. Fluid pressure sufficient to overcome the tension of the spring or other tensioning feature 178 can result in fluid flow in increasing degrees as pressure increases.
  • the disc 177 may be disposed against one or more seat portions 179, which may form an at least partially tapered surface against which the disc 177 may be sealed. With the disc 177 disposed against the seat 179, flow from the tube 175 may be prevented or substantially impeded, as well as backflow from the right atrial appendage 23 into the tube 175 and left atrial appendage 26.
  • the valve 176 may be configured to open only when fluid pressure exceeds a certain threshold level. Such threshold level may be set/governed by the tension characteristics of the spring/post component 178. In some implementations, the amount of fluid flow permitted through the valve 176 increases gradually (e.g., in a linear, semi-linear, logarithmic, or other manner) as the pressure level increases. In some embodiments, the characteristics of the disc 177 and/or disc support 173 (which may have a spring tension feature) may be designed/configured in order to set a pressure threshold above which the desired amount of blood flow may be permitted to flow.
  • valve disc 177 may comprise plastic, metal, and/or material(s).
  • Figures 18A and 18B show cross-sectional views of a fluid bypass conduit device 180 having a flow-limiter feature 187 in relatively closed and open configurations, respectively, in accordance with one or more embodiments.
  • the flow-limiting feature 187 may be a constrictor-type feature and may be formed through crimping or molding to produce a shape-set restricted shape as shown in Figure 18 A.
  • the tubular constriction 187 may be substantially around the circumference of at least a portion of the length of the tube 185.
  • Shape setting of the constricting feature 187 can be achieved by implementing one or more components of the device 180 using rubber and/or low-durometer plastic.
  • molded or pre-shaped silicon or similar material is used for at least a portion of the tube 185, including the constriction portion 183.
  • the entire tube may comprise a material constitution, wherein only the region 183 is shape-set to provide the flow-limiting effect.
  • shape of the constriction feature 187 is achieved using shape memory metal material, such as Nitinol or the like.
  • the constricted shape/configuration of the flow-limiting feature 187 may be relatively constricted in the presence of relatively lower fluid pressures, wherein increased fluid pressure causes the constricted portion to expand radially outward to thereby allow fluid flow through the region 183 of the tube 185, as shown in Figure 18 B.
  • the fluid bypass conduit device 180 comprises a stent with certain embedded material configured to be shape-set to the constricted configuration shown in Figure 18 A.
  • the constricted region 183 may be any length and/or positioned at any axial position along the tube 185.
  • the shape- set features and/or materials used for the constriction feature 187 may be selected/designed to prevent fluid flow through the region 183 in the presence of fluid pressures typically experienced and/or expected from the right side of the heart, such as within the right atrial appendage 23 and/or right atrium, whereas certain typical or expected pressure levels within the left atrial appendage 26 and/or left atrium may be sufficient to overcome the constricting force of the constriction feature 187, at least to some degree, to thereby allow a desired amount of fluid flow to be shunted from the left side of the heart the right side of the heart through the tube 185.
  • Conditional language used herein such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment.
  • indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.”
  • an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

Abstract

Une méthode de dérivation du sang consiste à accéder à une cavité thoracique d'un patient, former une première ouverture dans une première paroi du cœur du patient, la première paroi étant associée à une oreillette gauche du cœur, ancrer une première extrémité d'un conduit de fluide de pontage au moins partiellement sur la première ouverture, former une seconde ouverture dans une seconde paroi du cœur, la seconde paroi étant associée à une oreillette droite du cœur, et ancrer une seconde extrémité du conduit de fluide de pontage au moins partiellement sur la seconde ouverture.
EP20754581.5A 2019-08-06 2020-07-28 Dérivation de pontage cardiaque externe Pending EP4009903A1 (fr)

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PCT/US2020/043881 WO2021025905A1 (fr) 2019-08-06 2020-07-28 Dérivation de pontage cardiaque externe

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WO2020163659A1 (fr) * 2019-02-08 2020-08-13 NXT Biomedical Réduction de stase dans l'auricule gauche
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